ROSUVASTATIN HEC PHARM 20 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Rosuvastatin HEC Pharm is and what it is used for

• 2. What you need to know before you take Rosuvastatin

• 3. How to take Rosuvastatin

• 4. Possible side effects

• 5. How to store Rosuvastatin

• 6. Contents of the pack and other information

1. what rosuvastatin hec pharm is and what it is used for

Rosuvastatin HEC Pharm belongs to a group of medicines called statins.

You have been prescribed Rosuvastatin HEC Pharm because:

• You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Rosuvastatin HEC Pharm is used in adults, adolescents and children 6 years or older to treat high cholesterol.
• You have been advised to take a statin, because changing your diet and doing more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking Rosuvastatin HEC Pharm.

Or

• You have other factors that increase your risk of having a heart attack, stroke or related health problems.

Heart attack, stroke and other problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to build up of fatty deposits in your arteries.

Why it is important to keep taking Rosuvastatin HEC Pharm

Rosuvastatin HEC Pharm is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol.

There are different types of cholesterol found in the blood – ‘bad’ cholesterol (LDL-C) and ‘good’ cholesterol (HDL-C).

• Rosuvastatin HEC Pharm can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol.
• It works by helping to block your body’s production of ‘bad’ cholesterol. It also improves your body’s ability to remove it from your blood.

For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow.

Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, a stroke or related health problems.

You need to keep taking Rosuvastatin HEC Pharm , even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing build up of fatty deposits. However, you should stop if your doctor tells you to do so, or you have become pregnant.

2. what you need to know before you take rosuvastatin hec pharm

Do not take Rosuvastatin HEC Pharm:

• If you have ever had an allergic reaction to Rosuvastatin HEC Pharm, or to any of its ingredients.
• If you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin HEC Pharm stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin HEC Pharm by using suitable contraception.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle aches or pains.
• If you take a drug called ciclosporin (used for example, after organ transplants).

If any of the above applies to you (or you are in doubt), please go back and see your doctor.

In addition, do not take Rosuvastatin HEC Pharm 40 mg (the highest dose)

• If you have moderate kidney problems (if in doubt, please ask your doctor).
• If your thyroid gland is not working properly.
• If you have had any repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• If you take other medicines called fibrates to lower your cholesterol.

If any of the above applies to you (or you are in doubt), please go back and see your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rosuvastatin HEC Pharm.

• If you have problems with your kidneys.

Children and adolescents

• If the patient is under 6 years old: Rosuvastatin HEC Pharm should not be given to children younger than 6 years.
• If the patient is below 18 years of age: The Rosuvastatin HEC Pharm 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.

Other medicines and Rosuvastatin HEC Pharm

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following: ciclosporin (used for example, after organ transplants), warfarin or clopidogrel (or any other drug used for thinning the blood), fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe), indigestion remedies (used to neutralise acid in your stomach), erythromycin (an antibiotic), fusidic acid (an antibiotic – please see below and Warnings and precautions), an oral contraceptive (the pill), hormone replacement therapy or anti-viral medications such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including HIV or hepatitis C infection – please see Warnings and precautions). The effects of these medicines could be changed by Rosuvastatin HEC Pharm or they could change the effect of Rosuvastatin HEC Pharm.

If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Rosuvastatin HEC Pharm. Taking Rosuvastatin HEC Pharm with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

Pregnancy and breast-feeding

Do not take Rosuvastatin HEC Pharm if you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin HEC Pharm stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin HEC Pharm by using suitable contraception.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Most people can drive a car and operate machinery while using Rosuvastatin HEC Pharm-it will not affect their ability. However, some people feel dizzy during treatment with Rosuvastatin HEC Pharm. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin HEC Pharm contains lactose

If you have been told by your doctor that you have an intolerance to some sugars (lactose or milk sugar), contact your doctor before taking Rosuvastatin HEC Pharm.

Rosuvastatin HEC Pharm contains sodium

This medicines contains less than 1 mmol sodium (23 mg) per dose, i.e essentially “sodium free”.For a full list of ingredients, please see

Contents of the pack and other information

3. how to take rosuvastatin hec pharm

Always take this medicine as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Usual doses in adults

If you are taking Rosuvastatin HEC Pharm for high cholesterol:

Starting dose

Your treatment with Rosuvastatin HEC Pharm must start with the 5 mg or the 10 mg dose , even if you have taken a higher dose of a different statin before. The choice of your start dose will depend upon:

• Your cholesterol level.
• The level of risk you have of experiencing a heart attack or stroke.
• Whether you have a factor that may make you more sensitive to possible side effects.

Please check with your doctor or pharmacist which start dose of Rosuvastatin HEC Pharm will best suit you. Your doctor may decide to give you the lowest dose (5 mg) if:

• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• You are over 70 years of age.
• You have moderate kidney problems.
• You are at risk of muscle aches and pains (myopathy).

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the amount of Rosuvastatin HEC Pharm that is right for you. If you started with a 5 mg dose, your doctor may decide to double this to 10 mg then 20 mg and then 40 mg if necessary. If you started on 10 mg, your doctor may decide to double this to 20 mg and then 40 mg if necessary. There will be a gap of four weeks between every dose adjustment.

The maximum daily dose of Rosuvastatin HEC Pharm is 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attacks or stroke whose cholesterol levels are not lowered enough with 20 mg.

If you are taking Rosuvastatin HEC Pharm to reduce your risk of having a heart attack, stroke or related health problems:

The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

Use in children and adolescents aged 6-17 years

The dose range in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual start dose is 5 mg per day, and your doctor may gradually increase your dose to find the right amount of Rosuvastatin HEC Pharm for you. The maximum daily dose of Rosuvastatin HEC Pharm is 10 or 20 mg for children aged 6 to 17 years depending on your underlying condition being treated. Take your dose once a day. Rosuvastatin HEC Pharm 40 mg tablet should not be used by children.

Taking your tablets

Swallow each tablet whole with a drink of water.

Take Rosuvastatin HEC Pharm once daily. You can take it at any time of the day with or without food. Try to take your tablet at the same time every day to help you to remember it.

Regular cholesterol checks

It is important to go back to your doctor for regular cholesterol checks, to make sure your cholesterol has reached and is staying at the correct level.

Your doctor may decide to increase your dose so that you are taking the amount of Rosuvastatin HEC Pharm that is right for you.

If you take more Rosuvastatin HEC Pharm than you should

Contact your doctor or nearest hospital for advice.

If you go into hospital or receive treatment for another condition, tell the medical staff that you are taking Rosuvastatin HEC Pharm.

If you forget to take Rosuvastatin HEC Pharm

Don’t worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Rosuvastatin HEC Pharm

Talk to your doctor if you want to stop taking Rosuvastatin HEC Pharm. Your cholesterol levels might increase again if you stop taking Rosuvastatin HEC Pharm.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It is important that you are aware of what these side effects may be. They are usually mild and disappear after a short time.

Stop taking Rosuvastatin HEC Pharm and seek medical help immediately if you have any of the following allergic reactions:

• Difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat.
• Swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing.
• Severe itching of the skin (with raised lumps).

Also, stop taking Rosuvastatin HEC Pharm and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than you might expect. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects and rarely these have gone on to become a potentially life threatening muscle damage known as rhabdomyolysis.

Common possible side effects (these may affect between 1 in 10 and 1 in 100 patients):

• Headache, stomach pain, constipation, feeling sick, muscle pain, feeling weak, dizziness
• An increase in the amount of protein in the urine – this usually returns to normal on its own without having to stop taking your Rosuvastatin HEC Pharm tablets (only Rosuvastatin HEC Pharm 40 mg).
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon possible side effects (these may affect between 1 in 100 and 1 in 1,000 patients):

• Rash, itching or other skin reactions
• An increase in the amount of protein in the urine – this usually returns to normal on its own without having to stop taking your Rosuvastatin HEC Pharm tablets (only Rosuvastatin HEC Pharm 5 mg, 10 mg and 20 mg).

Rare possible side effects (these may affect between 1 in 1,000 and 1 in 10,000 patients):

• Severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat, difficulty in swallowing and breathing, a severe itching of the skin (with raised lumps).

If you think you are having an allergic reaction, then stop taking Rosuvastatin HEC Pharm and seek medical help immediately.

• Muscle damage in adults – as a precaution, stop taking Rosuvastatin HEC Pharm and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than expected.
• A severe stomach pain (inflamed pancreas).
• Increase in liver enzymes in the blood.
• Bleeding or bruising more easily than normal due to low level of blood platelets.

Very rare possible side effects (these may affect less than 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes), hepatitis (an inflamed liver), traces of blood in your urine, damage to the nerves of your legs and arms (such as numbness), joint pain, memory loss and breast enlargement in men (gynaecomastia).

Side effects of unknown frequency may include:

• Diarrhoea (loose stools), Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and genitals), cough, shortness of breath, oedema (swelling), sleep disturbances, including insomnia and nightmares, sexual difficulties, depression, breathing problems, including persistent cough and/or shortness of breath or fever, tendon injury, and muscle weakness that is constant.

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store rosuvastatin hec pharm

• Do not store above 30°C. Store in the original package.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the box/blisters/label after EXP. The expiry date refers to the last day of the month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationthe active substances are rosuvastatin.

Each film-coated tablet contains rosuvastatin calcium equivalent to 5 mg of rosuvastatin.

Each film-coated tablet contains rosuvastatin calcium equivalent to 10 mg of rosuvastatin.

Each film-coated tablet contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin.

Each film-coated tablet contains rosuvastatin calcium equivalent to 40 mg of rosuvastatin.

The other ingredients are:

Microcrystalline cellulose PH102, lactose monohydrate (see section 2), hydroxypropyl cellulose, croscarmellose sodium (see section 2), sodium bicarbonate (see section 2), magnesium stearate, titanium dioxide (E171), hypromellose (2910, 3 mPa.s), hypromellose (2910, 6 mPa.s), macrogol 400, polysorbate 80.

What Rosuvastatin HEC Pharm looks like and contents of the pack

Rosuvastatin HEC Pharm 5 mg tablet: White or almost white round film-coated tablets with diameter of 5.6 mm and thickness of 2.7 mm – 3.6 mm, debossed “L21” on one side and blank on the other side.

Rosuvastatin HEC Pharm 10 mg tablet: White or almost white round film-coated tablets with diameter of 7.1 mm and thickness of 3.3 mm – 4.5 mm, debossed “L22” on one side and blank on the other side.

Rosuvastatin HEC Pharm 20 mg tablet: White or almost white round film-coated tablets with diameter of 9.1 mm and thickness of 4.3 mm – 5.1 mm, debossed “L23” on one side and blank on the other side.

Rosuvastatin HEC Pharm 40 mg tablet: White or almost white round film-coated tablets with diameter of 9.1 mm and thickness of 4.2 mm – 5.3 mm, debossed “S74” on one side and blank on the other side.

Rosuvastatin HEC Pharm 5 mg tablet: Opaque white blisters (OPA/AL/PVC) in packs of 10, 28, 30, 90 and 100 film-coated tablets.

Rosuvastatin HEC Pharm 10 mg tablet: Opaque white blisters (OPA/AL/PVC) in packs of 10, 28, 30, 90 and 100 film-coated tablets.

Rosuvastatin HEC Pharm 20 mg tablet: Opaque white blisters (OPA/AL/PVC) in packs of 10, 28, 30, 90 and 100 film-coated tablets.

Rosuvastatin HEC Pharm 40 mg tablet: Opaque white blisters (OPA/AL/PVC) in packs of 10 and 28 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

HEC Pharm GmbH

Gabriele-Tergit-Promenade 17

10963 Berlin, Germany

Manufacturer

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305 b

14167 Berlin

Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

10963 Berlin

This leaflet was last revised in 01/2021.